CompletedPhase 2/3

PF-06651600 for the Treatment of Alopecia Areata

United States718 participantsStarted 2018-12-03

Plain-language summary

This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Who can participate

Age range12 Years

SexALL

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Inclusion Criteria: * Clinical diagnosis of alopecia areata with no other cause of hair loss * ≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months * Current episode of hair loss ≤10 years Exclusion Criteria: * Other types of alopecia or other diseases that can cause hair loss * Other scalp diseases that could interfere with assessment of hair loss/regrowth * Subjects with shaved heads must not enter the study until hair has grown back \& is considered stable by the investigator * Any previous use of any Janus kinase (JAK) inhibitor

What they're measuring

Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24

Timeframe: Week 24

Trial details

NCT IDNCT03732807

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-31

Results submitted2021-12-16

View on ClinicalTrials.gov More Alopecia Areata trials